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Early Extubation for Patients With Acute Hypoxemic Respiratory Failure

Primary Purpose

Mechanical Ventilation, Corona Virus Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helmet non-invasive ventilation (NIV)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mechanical Ventilation focused on measuring helmet interface NIV, early extubation, acute hypoxemic respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 years old on mechanical ventilation for at least 48 hours Positive End Expiratory Pressure (PEEP) level between 8 to 13cm H20 The ratio between the partial pressure of oxygen and fraction of inspired oxygen (PaO2/FiO2) between 150 and 300 mmHg with FiO2≤0.6 pH≥7.25 Respiratory rate (RR)≤30/min Adequate gag and cough reflex Ability to spontaneously breathe

Exclusion Criteria:

Hemodynamic instability (Systolic blood pressure <90 or requiring >2 vasoactive agents) Tracheostomy Upper airway obstruction Pregnancy Elevated intracranial pressure Upper airway obstruction Glasgow coma scale ≤ 8 Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach

Sites / Locations

  • University of Chicago Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Helmet non invasive ventilation (NIV)

Control invasive mechanical ventilation

Arm Description

Patients randomized to the intervention group will be extubated to helmet NIV.

Patients randomized to the control group will continue invasive mechanical ventilation. Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes. If the spontaneous breathing trial is successful, then the patient will be extubated.

Outcomes

Primary Outcome Measures

ventilator days
duration of mechanical ventilation via endotracheal tube

Secondary Outcome Measures

Intensive care unit (ICU) length of stay
number of days admitted to the ICU
need for re-intubation
number of patients requiring endotracheal intubation after extubation

Full Information

First Posted
April 14, 2020
Last Updated
February 23, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04349332
Brief Title
Early Extubation for Patients With Acute Hypoxemic Respiratory Failure
Official Title
Early Extubation for Patients With Acute Hypoxemic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the study is to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic.
Detailed Description
Single center randomized clinical trial investigating the efficacy of helmet NIV used for early liberation from mechanical ventilation in patients with acute hypoxemic respiratory failure. Intervention: Helmet group Patients randomized to the intervention group will be extubated to helmet NIV without a spontaneous breathing trial. The helmet will be connected to oxygen and room air flow meter to deliver a minimum of 60L of fresh gas flow and a PEEP valve. The PEEP will be increased using a PEEP valve in increments of 2-3 cmH20 to improve peripheral oxygen saturation of at least 90% at an inspired oxygen requirement (FiO2) of ≤ 60%.14 After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; this is a part of usual care for the management of patients with acute hypoxemic respiratory failure. Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay. Control: Usual Care Patient randomized to the control group will continue invasive mechanical ventilation until the following weaning criteria are met:15 Resolution or improvement of the condition leading to intubation Hemodynamic stability, defined as systolic blood pressure between 90 and 160 mm Hg and heart rate less than 140/min without vasopressors or with low doses of vasopressors Glasgow Coma Scale score of 13 or greater Respiratory stability (oxygen saturation >90% with fraction of inspired oxygen [Fio2] ≤0.4, respiratory rate <35/min, Noncopious secretions (<3 aspirations in the last 8 hours). Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes on pressure support mode. Criteria for failure to tolerate the SBT were agitation, anxiety, low level of consciousness (Glasgow Coma Scale score <13), respiratory rate higher than 35/min and/or use of accessory muscles, oxygen saturation by pulse oximetry less than 90% with Fio2 higher than 0.5, heart rate higher than 140/min or greater than a 20% increase from baseline, systolic blood pressure lower than 90 mm Hg, or development of arrhythmia. If the spontaneous breathing trial is successful, then the patient will be extubated. Subjects will be followed for long term followup at 90 day and 1year mortality

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Corona Virus Infection
Keywords
helmet interface NIV, early extubation, acute hypoxemic respiratory failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Helmet non invasive ventilation (NIV)
Arm Type
Active Comparator
Arm Description
Patients randomized to the intervention group will be extubated to helmet NIV.
Arm Title
Control invasive mechanical ventilation
Arm Type
No Intervention
Arm Description
Patients randomized to the control group will continue invasive mechanical ventilation. Once weaning criteria are met, patients will undergo a spontaneous breathing trial for 30 minutes. If the spontaneous breathing trial is successful, then the patient will be extubated.
Intervention Type
Device
Intervention Name(s)
Helmet non-invasive ventilation (NIV)
Intervention Description
After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
Primary Outcome Measure Information:
Title
ventilator days
Description
duration of mechanical ventilation via endotracheal tube
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Intensive care unit (ICU) length of stay
Description
number of days admitted to the ICU
Time Frame
up to 6 weeks
Title
need for re-intubation
Description
number of patients requiring endotracheal intubation after extubation
Time Frame
up to 6 weeks
Other Pre-specified Outcome Measures:
Title
hospital length of stay
Description
number of days spent in hospital during enrollment hospitalization
Time Frame
up to 6 weeks
Title
hospital mortality
Description
death from any cause during hospitalization time of enrollment
Time Frame
up to 6 weeks
Title
long term mortality
Description
death from any cause 90 day, 1year
Time Frame
up to 1 year
Title
ICU related complications
Description
including ventilator associated pneumonia, GI hemorrhage, DVT/PE, sacral decubitus ulcer, delirium, ICU acquired weakness
Time Frame
up to 6 weeks
Title
discharge location
Description
measure the location (home, rehabilitation center, nursing home)
Time Frame
up to 90 days
Title
health care utilization
Description
days alive and institution free
Time Frame
up to 6 weeks
Title
diaphragm ultrasound thickness
Description
ultrasound measurement at end expiration: enrollment, pre extubation, post extubation
Time Frame
up to 6 weeks
Title
diaphragm thickening fraction
Description
ultrasound measurement at end expiration and inspiration to calculate thickening fraction
Time Frame
up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old on mechanical ventilation for at least 48 hours Positive End Expiratory Pressure (PEEP) level between 8 to 13cm H20 The ratio between the partial pressure of oxygen and fraction of inspired oxygen (PaO2/FiO2) between 150 and 300 mmHg with FiO2≤0.6 pH≥7.25 Respiratory rate (RR)≤30/min Adequate gag and cough reflex Ability to spontaneously breathe Exclusion Criteria: Hemodynamic instability (Systolic blood pressure <90 or requiring >2 vasoactive agents) Tracheostomy Upper airway obstruction Pregnancy Elevated intracranial pressure Upper airway obstruction Glasgow coma scale ≤ 8 Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bhakti Patel, MD
Phone
773-702-6800
Ext
3349
Email
bpatel@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Pohlman, MSN
Phone
773-702-3804
Email
apohlman@medicine.bsd.uchicago.edu
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhakti Patel, MD
Email
bpatel@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Anne Pohlman, MSN
Email
apohlman@medicine.bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Extubation for Patients With Acute Hypoxemic Respiratory Failure

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